A study of determine if genes influence the response to chemotherapy in patients with cancer of the mouth

Not Applicable

• Conditions: Health Condition 1: null- Patient with Cancer of Gingivobuccal Complex

• Registration Number: CTRI/2014/09/005002
• Lead Sponsor: DBT

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 12

Inclusion Criteria

1.Previously untreated borderline resectable GB SCC i.e T4a lesions

2.Histological proven diagnosis of squamous cell cancer

3.Signed informed consent

4.Adequate organ function

•Hematological- Hb > 9 g/dL, ANC >= 1.5 x 109/L, platelets >= 100 x 109/L.

•Liver functions- bilirubin<= 2x upper limit normal (ULN), S. albumin>=30 g/L.

•Renal function- Creatinine <= 2 ULN, Creatinine clearance > 30 mL/min.

•Performance score (KPS) > 80 or ECOG <= 2

Exclusion Criteria

1.Distant metastasis present

2.Serious co-morbidities such as severe cardiac failure or severe pulmonary compromise or severe and active infections.

3.Patients not suitable for any chemotherapy.

4.Patient is currently enrolled in a clinical trial for another investigational therapy.

5.Pregnancy

6.Patients in whom chemotherapy is advised for a palliative intent will not be considered for the study because chemotherapy will be very varied and may be metronomic in nature which will cause wide differences in the final analysis

Study & Design

• Study Type: Observational
• Study Design: Not specified